CelluliteNCT04830722
Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs
A study testing Sculptra Aesthetic in people with Cellulite, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
clinical trial is to assess the safety, efficacy and patient satisfaction associated with the treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Sculptra Aesthetic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult females age 30 to 60
- Both buttocks and/or both posterolateral thighs with a score of mild (1-5) to moderate (6-10 according to the Hexsel, Dal'Forno \& Hexsel Cellulite Severity Scale (CSS), and a laxity score using the Hexsel, Dal'Forno \& Hexsel Cellulite Severity Scale of 1 (slight) or 2 (moderate). Must be the same score on both sides of the same area (ie: if 1 on one buttock, must be 1 on the other buttock but can be a 2 on the thigh, as long as the other thigh is also a 2)
- Must be willing to give and sign an informed consent form and photographic release form.
- Must have had a stable body weight for at least 6 months prior to study entry.
- Must be willing to maintain usual sun exposure, diet, and exercise routines for the duration of the study.
- Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study.
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- Negative urine pregnancy test results at the time of study entry (if applicable).
- For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation.
- A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
- Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and/or vasectomies of partner with a documented second acceptable method of birth control, should the subject become sexually activity.
- Must be willing to comply with study treatments and complete the entire course of the study.
- Cellulite that improves when the skin of the buttocks or thighs are stretched or distended superiorly.
Who cannot join
- Use of any of the following for the treatment of cellulite on either thigh or either buttock within the timelines identified below or intends to use any of the following at any time during the course of the study:
- Liposuction during the 12-month period prior to study treatment.
- Injections (eg, mesotherapy, dermal fillers, biostimulatory fillers, clostridium collagenase histolyticum); radiofrequency device treatments; laser treatment; buttock or thigh implant treatment; cryolipolysis; or surgery (including subcision and/or powered subcision) during the 24-month period before injection of study treatment.
- Any investigational treatment for cellulite on a buttock or thigh during the 12-month period before the injection of study treatment.
- Endermologie or similar treatments during the 6 month period before injection of study treatment.
- Massage therapy during the 3-month period before injection of study treatment.
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- Creams (eg, Tretinoin, Celluvera™, TriLastin®) and/or home therapies to prevent or treat cellulite during the two week period before injection of study treatment.
- Subjects with scarring in treatment areas.
- Has any of the following local conditions in the areas to be treated (both buttocks or both thighs):
- History of lower extremity thrombosis or post-thrombosis syndrome.
- Vascular disorder (eg, varicose veins)
- A subject with tattoos or permanent implants in the treatment areas.
- A subject with history of or the presence of any skin condition/disease in the treatment area that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
- Subject who spray tanned or used sunless tanner in the treatment area 4 weeks prior to study treatment.
- A subject with an active bacterial, fungal, or viral infection in the treatment area.
- A subject with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- Any history of bleeding or coagulation disorders.
- History of lidocaine sensitivity deemed by the investigator to preclude patient from enrolling in the study.
- A subject planning any other cosmetic procedure to the study treatment area during the study period, other than the treatment that will be performed by the investigator.
- Presence of incompletely healed wound in treatment area.
- Non-Ablative laser to the treatment area in the last 3 months.
- A female subject who is pregnant, nursing an infant or planning a pregnancy during the study.
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cosmetic Laser Dermatology/West Dermatology Research Center
San Diego, California, 92121
Leslie Aguilar, BA, 858-657-1004, LAguilar@CLDerm.com
Sherif Mikhail, MD, 8586571004, SMikhail@clderm.com
About this study
Official title: A Randomized Single Center, Double Blinded, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs
clinical trial is to assess the safety, efficacy and patient satisfaction associated with the treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic
Read the detailed description
Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of Sculptra Aesthetic, performed 1 month apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic water, injected in the same manner as Sculptra Aesthetic. Up to four (4) vials of Sculptra Aesthetic, diluted at 16 mL, will be used per treatment session.
- Conditions
- Cellulite
- Being tested
- Sculptra Aesthetic
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra AestheticDevice
One treatment side treated with Sculptra will be compared to the other side treated with bacteriostatic water (placebo) -same volume
| Study group | Role | What they receive |
|---|---|---|
| Sculptra Aesthetic Side | Active comparator | the treatment area side (an area side is considered either buttock and/or thigh) (left or right-depends on randomization) will receive up to two vials of Sculptra Aesthetic, for a total of 4 vials in one treatment session if 2 areas qualify. Receives: Device: Sculptra Aesthetic |
| Placebo side | Placebo comparator | the treatment area side (an area side is considered either buttock and/or thigh) (left or right-depends on randomization) will receive 16 cc of bacteriostatic water, for up to 64 ccs of bacteriostatic water to match the volume injected on the active side Receives: Device: Sculptra Aesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Safety
Assessing safety of treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX) using Evaluation of side effects by subject and investigator
Measured: 1 year
Assessing Efficacy
Assessing efficacy of treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX) using Subject and Blinded Investigator GAIS and Blinded Investigator Hexsel Grading Scale, Galderma Cellulite Grading Scale, and end of study iodentification of correct treatment side using side by side photography before unblinding.
Measured: 1 year
Assessing Patient Satisfaction
Assessing patient satisfaction of treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX) using a patient satisfaction questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start9 Apr 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of Sculptra Aesthetic, performed 1 month apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic water, injected in the same manner as Sculptra Aesthetic.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Leslie Laser Aguilar, Goldman, Butterwick, Fitzpatrick and Groff
- Investigators
- Sabrina Fabi, MD, Principal investigator, Cosmetic Laser Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830722
- Sponsor's protocol ID
- Sculptra-Aesthetic-2021
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Haddad A, Menezes A, Guarnieri C, Coimbra D, Ribeiro E, Sarubi J, Avelar LE, Del Nero MP, da Cunha MG, Mazzuco R, Kamamoto C, Cazerta C. Recommendations on the Use of Injectable Poly-L-Lactic Acid for Skin Laxity in Off-Face Areas. J Drugs Dermatol. 2019 Sep 1;18(9):929-935.
PubMed 31524350Narins RS, Baumann L, Brandt FS, Fagien S, Glazer S, Lowe NJ, Monheit GD, Rendon MI, Rohrich RJ, Werschler WP. A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol. 2010 Mar;62(3):448-62. doi: 10.1016/j.jaad.2009.07.040.
PubMed 20159311Jabbar A, Arruda S, Sadick N. Off Face Usage of Poly-L-Lactic Acid for Body Rejuvenation. J Drugs Dermatol. 2017 May 1;16(5):489-494.
PubMed 28628686Davis DS, Boen M, Fabi SG. Cellulite: Patient Selection and Combination Treatments for Optimal Results-A Review and Our Experience. Dermatol Surg. 2019 Sep;45(9):1171-1184. doi: 10.1097/DSS.0000000000001776.
PubMed 30913048Uebel CO, Piccinini PS, Martinelli A, Aguiar DF, Ramos RFM. Cellulite: A Surgical Treatment Approach. Aesthet Surg J. 2018 Sep 14;38(10):1099-1114. doi: 10.1093/asj/sjy028.
PubMed 29432568Mazzuco R, Sadick NS. The Use of Poly-L-Lactic Acid in the Gluteal Area. Dermatol Surg. 2016 Mar;42(3):441-3. doi: 10.1097/DSS.0000000000000632. No abstract available.
PubMed 26859651Lin MJ, Dubin DP, Khorasani H. Poly-L-Lactic Acid for Minimally Invasive Gluteal Augmentation. Dermatol Surg. 2020 Mar;46(3):386-394. doi: 10.1097/DSS.0000000000001967.
PubMed 31188150
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single Center, Double Blinded, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs
- ClinicalTrials.gov ID
- NCT04830722
- Acronym / sponsor ID
- Sculptra-Aesthetic-2021
- Conditions
- Cellulite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
clinical trial is to assess the safety, efficacy and patient satisfaction associated with the treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic
Detailed description
Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of Sculptra Aesthetic, performed 1 month apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic water, injected in the same manner as Sculptra Aesthetic. Up to four (4) vials of Sculptra Aesthetic, diluted at 16 mL, will be used per treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of Sculptra Aesthetic, performed 1 month apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic water, injected in the same manner as Sculptra Aesthetic.
| Arm | Type | Receives |
|---|---|---|
| Sculptra Aesthetic Side | Active comparator | Device: Sculptra Aestheticthe treatment area side (an area side is considered either buttock and/or thigh) (left or right-depends on randomization) will receive up to two vials of Sculptra Aesthetic, for a total of 4 vials in one treatment session if 2 areas qualify. |
| Placebo side | Placebo comparator | Device: Sculptra Aestheticthe treatment area side (an area side is considered either buttock and/or thigh) (left or right-depends on randomization) will receive 16 cc of bacteriostatic water, for up to 64 ccs of bacteriostatic water to match the volume injected on the active side |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy adult females age 30 to 60
- Both buttocks and/or both posterolateral thighs with a score of mild (1-5) to moderate (6-10 according to the Hexsel, Dal'Forno \& Hexsel Cellulite Severity Scale (CSS), and a laxity score using the Hexsel, Dal'Forno \& Hexsel Cellulite Severity Scale of 1 (slight) or 2 (moderate). Must be the same score on both sides of the same area (ie: if 1 on one buttock, must be 1 on the other buttock but can be a 2 on the thigh, as long as the other thigh is also a 2)
- Must be willing to give and sign an informed consent form and photographic release form.
- Must have had a stable body weight for at least 6 months prior to study entry.
- Must be willing to maintain usual sun exposure, diet, and exercise routines for the duration of the study.
Key exclusion criteria (23 listed)
- Use of any of the following for the treatment of cellulite on either thigh or either buttock within the timelines identified below or intends to use any of the following at any time during the course of the study:
- Liposuction during the 12-month period prior to study treatment.
- Injections (eg, mesotherapy, dermal fillers, biostimulatory fillers, clostridium collagenase histolyticum); radiofrequency device treatments; laser treatment; buttock or thigh implant treatment; cryolipolysis; or surgery (including subcision and/or powered subcision) during the 24-month period before injection of study treatment.
- Any investigational treatment for cellulite on a buttock or thigh during the 12-month period before the injection of study treatment.
- Endermologie or similar treatments during the 6 month period before injection of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sculptra AestheticOne treatment side treated with Sculptra will be compared to the other side treated with bacteriostatic water (placebo) -same volume | Device | Placebo side, Sculptra Aesthetic Side |
Primary outcome
Assessing Safety
Time frame: 1 year
Assessing safety of treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX) using Evaluation of side effects by subject and investigator
Assessing Efficacy
Time frame: 1 year
Assessing efficacy of treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX) using Subject and Blinded Investigator GAIS and Blinded Investigator Hexsel Grading Scale, Galderma Cellulite Grading Scale, and end of study iodentification of correct treatment side using side by side photography before unblinding.
Assessing Patient Satisfaction
Time frame: 1 year
Assessing patient satisfaction of treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX) using a patient satisfaction questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Background: PubMed 31524350Haddad A, Menezes A, Guarnieri C, Coimbra D, Ribeiro E, Sarubi J, Avelar LE, Del Nero MP, da Cunha MG, Mazzuco R, Kamamoto C, Cazerta C. Recommendations on the Use of Injectable Poly-L-Lactic Acid for Skin Laxity in Off-Face Areas. J Drugs Dermatol. 2019 Sep 1;18(9):929-935.
- Background: PubMed 20159311Narins RS, Baumann L, Brandt FS, Fagien S, Glazer S, Lowe NJ, Monheit GD, Rendon MI, Rohrich RJ, Werschler WP. A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol. 2010 Mar;62(3):448-62. doi: 10.1016/j.jaad.2009.07.040.
- Background: PubMed 28628686Jabbar A, Arruda S, Sadick N. Off Face Usage of Poly-L-Lactic Acid for Body Rejuvenation. J Drugs Dermatol. 2017 May 1;16(5):489-494.
- Background: PubMed 30913048Davis DS, Boen M, Fabi SG. Cellulite: Patient Selection and Combination Treatments for Optimal Results-A Review and Our Experience. Dermatol Surg. 2019 Sep;45(9):1171-1184. doi: 10.1097/DSS.0000000000001776.
- Background: PubMed 29432568Uebel CO, Piccinini PS, Martinelli A, Aguiar DF, Ramos RFM. Cellulite: A Surgical Treatment Approach. Aesthet Surg J. 2018 Sep 14;38(10):1099-1114. doi: 10.1093/asj/sjy028.
- Background: PubMed 26859651Mazzuco R, Sadick NS. The Use of Poly-L-Lactic Acid in the Gluteal Area. Dermatol Surg. 2016 Mar;42(3):441-3. doi: 10.1097/DSS.0000000000000632. No abstract available.
- Background: PubMed 31188150Lin MJ, Dubin DP, Khorasani H. Poly-L-Lactic Acid for Minimally Invasive Gluteal Augmentation. Dermatol Surg. 2020 Mar;46(3):386-394. doi: 10.1097/DSS.0000000000001967.
- Accessed September 18th 2020Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina Fabi, MD principal investigator
Cosmetic Laser Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sculptra Aesthetic in people with Cellulite, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif Research Director, MD (8586571004, SMikhail@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Safety (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04830722, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.